FDA 510(k)

Natrelle 133S组织扩张器

K号: K182054 · 2018-08-29

决定日期2018-08-29

产品代码LCJ

决定实质等同

器械摘要

Natrelle 133S Tissue Expander is the device name listed in this FDA 510(k) record. The listed applicant is Allergan. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K182054. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

常见问题

What is the Natrelle 133S Tissue Expander?

Natrelle 133S Tissue Expander is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Allergan. The 510(k) number is K182054.

When did Natrelle 133S Tissue Expander receive FDA 510(k) clearance?

Natrelle 133S Tissue Expander received FDA 510(k) clearance on 2018-08-29, under 510(k) number K182054.

Who is the listed applicant for Natrelle 133S Tissue Expander?

The FDA 510(k) record lists Allergan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Natrelle 133S Tissue Expander?

The FDA product code for Natrelle 133S Tissue Expander is LCJ.

列明Allergan为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K203229NATRELLE INSPIRA 一次性凝胶植入物测量器 K193589TrueTear 鼻腔泪液神经刺激器 K180826Natrelle 133 Plus MICROCELL组织扩张器

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。